Strativa Pharmaceuticals Provides Product Pipel...( Files NDA for Ondansetron Orally Diss...),Health

Files NDA for Ondansetron Orally Dissolving Film Strip

BioAlliance to Resubmit Loramyc(R) NDA

WOODCLIFF LAKE, N.J., April 9 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today provides an update on two of its pipeline products.

Ondansetron Orally Dissolving Film Strip

On April 7, 2009, Strativa submitted a New Drug Application (NDA) for its new orally dissolving film strips (ODFS) formulation of ondansetron to the U.S. Food and Drug Administration (FDA). Strativa is seeking approval of ondansetron ODFS in 8 mg and 4 mg strengths for the prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of post-operative nausea and vomiting.

A program consisting of three separate pivotal studies comparing the bioequivalence of ondansetron ODFS 8mg to Zofran ODT(R) 8mg was completed in December 2008 and supports the NDA filing of ondansetron ODFS. The pharmacokinetic results of each study demonstrate that a single dose of ondansetron ODFS, taken with or without water, is bioequivalent to Zofran ODT, taken under similar conditions.

The antiemetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescription leader in the category, accounting for 95% of prescriptions.

In June 2008, Strativa acquired the commercialization rights in the United States and its territories to ondansetron ODFS from MonoSol Rx. To date, Strativa has paid MonoSol Rx a total of $3.5 million for the completion of certain milestones.

Loramyc(R) (miconazole Lauriad) for the treatment of oropharyngeal candidiasis (OPC)

After preliminary review, the FDA h
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